Senior Director Global Quality Assurance, Audits & Inspections

Overview

The Senior Director Global Quality Assurance, Audits & Inspections will be responsible for audit/CAPA activity timeline management, review of proposed audit observation/CAPA responses and proposed actions as well as Quality support across various functions. The incumbent will be responsible for contributing to the development and implementation of the global strategy and policy relative to quality management systems for FUJIFILM Diosynth Biotechnologies (FDB) to ensure excellence in compliance and the ability to withstand internal and external scrutiny. The incumbent will ensure that internal audit controls are implemented and are evaluated for compliance through audits and assessments across the FDB functions to minimize regulatory, legal, and business risk while effectively and efficiently supporting business goals. The incumbent will be responsible for leading the audits and inspection aspects of the Quality Systems and ensure compliance with company’s procedures, company policies, and regulatory guidelines. The role will be responsible for crafting, implementing, and driving an innovative corporate audit and inspection program. The individual will be sought out as the audit and inspection authority and will lead teams of quality professionals to ensure quality and compliance adherence to corporate audit and inspection program.

External US

At FUJIFILM Diosynth Biotechnologies, an exciting opportunity awaits you to collaborate with some of the most innovative biopharma companies worldwide. Here you will have the chance to learn from some of the most dedicated scientists, engineers, and manufacturers who are deeply committed to making an impact on people’s lives. We are different. We strive for better. Our people never settle for the status quo and as you push the boundaries of your potential, you not only change your life, you change others’ too. Our global team are looking for someone who shares our passion, drive, and energy – what we call Genki. Join us as our Senior Director Global QA, Audits and Inspections, and commit your life’s work to impacting where it matters most: human lives.

FUJIFILM Diosynth Biotechnologies (FDB) is transforming the customer experience – using trust as the cornerstone of our effort. Our Partners for Life Strategy lays out the direction for us to be the leading and most trusted CDMO in the biopharmaceutical industry. To further enable this strategy, we are looking for a Senior Director, Global Quality Assurance Systems, Audits and Inspections to join our Global QA Systems Leadership Team that oversees GxP activities at FDB. In this role you will be responsible for providing global strategic direction and leadership for the Global Quality audit program to assure compliance with regulatory requirements across FDB as well as supporting the continuous improvements of the FDB Quality Systems. You will have accountability for the audit program, assuring independent oversight, effectiveness in delivery on objectives and a strong quality voice. Advanced leadership skills and a partnership mindset, anchored by expert knowledge of the regulations governing preclinical research, drug development and post marketing activities (i.e., GCP, GLP/GCLP, and GMP), as well as a keen understanding of process controls will enable success in this role. This role will work closely with internal QA leads/stakeholders and external suppliers to assist in the planning, scheduling, conducting, and leading all aspects of GxP audits. They will collaborate internally and externally with internal manufacturing sites as well as Contract Service Providers (CSPs) for activities in compliance in Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and Good Manufacturing (GMP).

Main Activities and Responsibilities:

• Develop risk-based corporate audit strategy.
• Supervising activities related to inspection readiness, hosting and coordinating GxP inspections conducted by regulatory health authorities such as FDA, EMA, CFDI, MFDS, PMDA, TGA, etc.
• Developing, maintaining and ensuring the execution of a risk-based, proactive GxP Inspection Strategy
• Ensure the development of inspection risk-analyses and risk-mitigation plans and communicating to relevant cross-functional and Quality Leadership
• Supervising/Managing the collaboration with cross-functional internal and external partners to ensure a unified, optimal inspection strategy.
• Ensure the development, revision and maintenance of optimal tools, processes and procedures for inspection readiness, coordination and management.
• Ensure the creation and execution of the GxP Inspection Strategy
• Lead a team of Quality professionals and/ or consultants to carry out all defined GxP Inspection Readiness, Management and Hosting activities
• Collaborate with relevant cross-functional leaders to ensure a unified, opt